Immunological technologies have provided for major advances in therapeutic and diagnostic techniques in cancer diagnosis and both in vitro and in vivo cancer therapy. Numerous tumor-associated antigens have been characterized and polyclonal and monoclonal antibodies specifically immunoreactive with such have been proposed for use as diagnostic and prognostic aids in the clinical management of tumor disease states.
Of interest to the background of the invention are references generally relating to useful monoclonal antibodies raised against human tumor cells (see, e.g., Chen, U.S. Pat. No. 4,618,585) and especially the following references generally relating to monoclonal antibodies immunoreactive with various tumor-associated antigens such as CA 19-9, CA 125 and carcinoembryonic antigen (CEA) and to diagnostic tests based on the use of one or more of such antibodies: Del Villano, WO 84/00758 (CA 19-9); Safi, et al., Cancer, 5, 779-782 (1986) (CA 19-9); Brochure published by Centocor, "Carbohydrate Antigen 19-9 Radioimmunoassay", (1983) (CA 19-9); Del Villano, et al., Clin. Chem., 29 3, 549-552 (1983) (CA 19-9); De Favero, et al., Cancer, 57, 1576-1579 (1986) (CA 19-9); Gupta, et al., Cancer, 56, 277-283 (1985) (CA 19-9); Brochure published by Centocor relating to CA 125, (1983); Bergmann, et al., Cancer, 59, 213-217 (1987) (CA 125); Pinto, et al., Cancer, 59, 218-222 (1987) (CA 125); Brochure published by Centocor relating to CA 19-9 and CEA (1984); and Bast, et al., New Eng. J. Med., 309/15, 883-920 (1983) (CA 125); Brochure published by Centocor, "Centocor Cancer Antigen 125.TM.) Radioimmunoassay" (1983) (CA 125); Bast, et al., Am. J. Obstet. Gynecol., 149/5, 553-559 (1984) (CA 19-9, CA 125, and CEA).
Of interest to the background of the present invention are the following references relating to the diagnosis of prostate cancer disease states on the basis of elevated levels of marker substances such as "prostate specific antigen" (PA) and prostatic acid phosphatase (PAP) which are present in low levels in normal human serum and the serum of patients with benign prostatic hyperplasia, but present at higher levels in sera of prostatic carcinoma patients, especially those in an advanced disease state: Lin, et al., U.S. Pat. No. 4,298,592; Lee, et al., U.S. Pat. No. 4,267,272; Miller, et al., U.S. Pat. No. 4,510,239; and, European Patent Application No. 160228 published Nov. 6, 1985.
Of substantial interest to the background of the invention with respect to immunological methods for diagnosis of prostate cancer are the following references relating to monoclonal antibodies raised against human prostate tumor cell lines PC-3 and DU145: Ware, et al., Cancer Research, 42, 1215-1222 (April 1982) (PC-3); Raynor, et al., J.N.C.I., 73, 617-625 (1984) (PC-3); Carroll, et al., Clinical Immunology and Immunopathology, 33, 268-281 (1984) (PC-3); Starlinq, et al., Cancer Research, 42, 3084-3089 (1982) (DU-145); Starling and Wright, Cancer Research, 45, 804-808 (1985) (DU-145); and Wright, et al., Cancer Research, 43, 5509-5516 (1983) (PC-3 and DU-145).
Also of interest to the background of the invention are the following references relating to the diagnosis of breast cancer disease states on the basis of monoclonal antibodies raised against various breast tumor cell lines and breast tissues: Schlom, et al., U.S. Pat. No. 4,612,282; Hilkens, et al., Prot. Bio Fluids. 29, 813-816 (1981); Hilkens, et al., Prot. Bio. Fluids, 31, 1013-1016 (1984); Dempsey, et al., J.N.C.I., 77, 1-9 (1986); Papsidero, et al., Cancer Research, 43, 1741-1747 (1983); Brochure published by Centocor, "Centocor CA 15-3 Radioimmunoassay" (1985); Brochure published by Centocor, "Radioimmunoassay for the Detection of CA 15-3 in Serum or Plasma" (1986) and the further references cited therein; Hilkens, et al., Int. J. Cancer, 34, 197-206 (1984); Kofe, et al., Hybridoma, 3, 223-232 (1984); Sekine, et al., J. Immunology, 135 3610-3615 (1985); and, Schmidt-Rhode, et al., International Society for Oncodevelopmental Biology and Medicine, Sept. 10-13, Paris, 1985.
Despite the above noted advances in the art, there continues to exist a need for methods and materials useful in accurately detecting and monitoring prostate or breast tumor disease states.